Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Compliance Corner: Being MDSAP-Ready Helpful While FDA Foreign Inspections Paused, Expert Says

Executive Summary

King & Spalding’s Eric Henry urges manufacturers – particularly ones with facilities outside the US – to be prepared for a virtual audit under the Medical Device Single Audit Program. He explains how.

You may also be interested in...



On-Site Inspections Of US Device Makers Plummet 93% As FDA Scrambles For Virtual Solutions

A sharp decline in the number of in-person facility inspections has forced the FDA to consider creative techniques for remotely evaluating manufacturer compliance during the COVID-19 pandemic. This and other stories topped our list of most-read Medtech Insight articles in November.

Guidance Clarifies EU Position On Alternatives To Notified Body On-Site Audits

Virtual notified body audits of medtech manufacturers are already taking place through necessity. Now there is guidance concerning if, when, where and how these audits should be carried out.

Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot

In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT143188

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel